MalfunctionFLE
AMSCO
Received Sep 5, 2025 · Event occurred Aug 6, 2025
Report 3005899764-2025-00072 · MDR key 22976357
Device
Generic name
Amsco 600 Sterilizer
Manufacturer
Steris Mexico, S. De R.l. De C.v.Model number
AMSCO 600 STEAM STERILIZERCatalog number
EF1101242
Product problems
- Leak/Splash
- Leak/Splash
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE USER FACILITY REPORTED A WATER AND STEAM LEAK FROM THEIR AMSCO 600 STERILIZER. NO REPORT OF INJURY.
Additional Manufacturer Narrative
A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE UNIT AND FOUND THAT THE RUBBER COUPLER AROUND THE DRAIN PIPING WAS DAMAGED RESULTING IN THE REPORTED EVENT. TO RESOLVE THE ISSUE, THE TECHNICIAN REPLACED THE COUPLER. THE UNIT WAS TESTED, CONFIRMED TO BE OPERATING ACCORDING TO SPECIFICATION, AND RETURNED TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.